Developing Therapies that Change People's Lives

A Professional-Caliber Contract Research Organization with Top Academic Expertise

  • Clinical Coordination
  • Biostatistics & Data Management
  • Therapeutic Expertise
  • Recent Sponsored Trials
  • Clinical Coordinating Center (CCC)
  • Centralized CT Reading Center
  • Surgical Support Center
  • Investigator Selection & Qualification
  • Clinical Site Management
  • Safety & Pharmacovigilance
  • On-site and Remote QA Monitoring
  • Regulatory (IND, IDE, GCP)
  • Data Coordinating Center (DCC)
  • Clinical Data Management
  • Advanced Biostatistics
  • Adaptive Randomization
  • Electronic Data Capture (EDC)
  • Electronic Trial Master File (eTMF)
  • Clinical Trial Management System (CTMS)
  • Online Training & Certification
  • Hemorrhagic Stroke (ICH, IVH)
  • Ischemic Stroke, TIA
  • Global Ischemia
  • Traumatic Brain Injury (TBI)
  • Encephalitis
  • Functional & Cognitive Outcomes
  • Epilepsy
  • Neurosurgery
  • CLEAR A, a 16-patient phase-1 study of thrombolysis in IVH
  • CLEAR B, a 34-patient, phase-1 study of thrombolysis in IVH
  • MISTIE-II, a phase-II trial of thrombolysis in ICH
  • MISTIE-ICES, endoscopic evacuation in ICH
  • CLEAR-III, a 500-patient global trial in IVH
  • MISTIE-III, a 500-patient global trial in ICH
  • SLEUTH, feasibility of an ultrasound catheter in ICH
  • CARES, an 88-patient observational study

Brain Injury Outcomes (BIOS) is a research coordinating center at Johns Hopkins University, Department of Neurology.

Under the direction of Daniel F. Hanley, MD, a renowned expert in ischemic and hemorrhagic stroke, and with the managerial expertise of Karen Lane, since 1999, BIOS has been awarded more than 40 research grants from the National Institutes of Health (NIH), the FDA Orphan Drugs Program, pharmaceutical & medical device companies and medical societies. With the team's unique expertise, BIOS leads an international consortium of hospitals and medical institutions developing potentially life-saving new medical therapies for stroke and brain injury. Notable BIOS successes are the MISTIE and CLEAR programs, which are developing what could become the first validated treatments for hemorrhagic stroke, a form of bleeding in the brain.

The primary focus of BIOS is the design, oversight and analyses of neurological and neurosurgical clinical trials, whether conducted by investigators within the Johns Hopkins University system or through various national and international consortia. To organize these tasks, the Department of Neurology established a dedicated clinical trial management center that conducts activities under the moniker Brain Injury Outcomes Service (BIOS).

Acting as a Clinical Coordinating Center (CCC) and/or Data Coordinating Center (DCC) in some trials, and in others, in what is more generally described outside the academic setting as a full-service Contract Research Organization (CRO), BIOS has been coordinating multicenter drug, biologic and medical device trials for more than a decade. Functional expertise includes clinical strategy, project/site management, investigator selection & qualification, data management, quality assurance, pharmacovigilance, biostatistics, medical writing and regulatory compliance activities. Therapeutic expertise spans the full gamut of neurocritical/neurosurgical care with a primary focus on functional and cognitive outcomes following stroke and brain injuries.

Using its experienced in-house staff, an expansive network of clinical trial professionals and collaborators such as Emissary International, as well as access to the full resources of JHU, BIOS conducts large, complex, multicenter clinical trials on a global scale.

Brain Injury Outcomes

Johns Hopkins University
1550 Orleans Street
CRB-II, 3M50 South
Baltimore, MD 21231 USA
Office:   (410) 614-6996
Fax: (410) 502-7869
24-Hr: (410) 736-1368

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